MedDataX Logo

Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners

NCT ID: NCT04632979

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-03

Study Completion Date

2020-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will look to evaluate the feasibility of a backwards downhill running program as an option for the treatment of Achilles tendinopathy in runners. It is known that exercise on the Achilles tendon during elongation (eccentric exercise) improves tendon function after injury. However, during recovery, the patient is required to stop tendon-loading activities such as jumps and sprints. Therefore, during recovery, athletes decline in physical fitness.

Backward running on a negative slope can achieve a biomechanical load similar to eccentric exercise without decreasing physical fitness.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was a prospective, single-arm feasibility study. Participants were patients who met the entry criteria and were referred to the Meuhedet health service Physical Therapy outpatient clinic, Jerusalem, from September 2019 to February 2020. The sample size was based on previous recommendations for pilot and feasibility studies (Julious 2005; Billingham, Whitehead, and Julious 2013). Inclusion criteria were: AT that was clinically determined by an orthopedic surgeon (E.S) according to nontraumatic pain and tenderness at the Achilles tendon and report of decreased activity levels secondary to Achilles pain; a history of running for at least one session a week in the past three months; age \> 18 and \< 70. Exclusion criteria were having other lower extremity injuries; prior treatment with eccentric exercise or currently receiving Physical Therapy for AT; received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.

Participants received a total of nine treatment sessions, twice a week for a total of five weeks. Each treatment consisted of backward walking / running over an 8ยบ negatively inclined treadmill. (Landice L7 Rehabilitation treadmill, New Jersey, USA) with a warmup and a cooldown on a stationary bike. A detailed description of the protocol is presented in Table 1. As backward locomotion on a treadmill was novel for all participants they were advised to hold the treadmill handles during the adjustment period (treatment sessions 1-3). Participants were also instructed to refrain from specific sports which involve continuous jumping and forward running throughout the intervention period. Patients were informed that if they do not feel comfortable with the training protocol, they could terminate their participation at any point.

Assessments took place at baseline, pretreatment four, pretreatment six, and at a separate meeting after treatment nine

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Achilles Tendinopathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Achilles tendinopathy backward running exercise running overuse injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Backward runners

Training protocol patients

Group Type EXPERIMENTAL

Backwards running on a Treadmil with a negative slope

Intervention Type PROCEDURE

Running backward on a treadmill with a negative slope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Backwards running on a Treadmil with a negative slope

Running backward on a treadmill with a negative slope

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Distinct tenderness of Achilles tendon with no pain in the neighboring structures.
2. Nontraumatic diffuse pain in the posterior calf with local tenderness in the Achilles tendon.
3. A history of running for at least one session a week in the past three months.
4. Age \> 18 and \< 70

Exclusion Criteria

1. Achilles pain longer than six months.
2. Patients with an additional lower extremity injury unable to bear full weight on the limb.
3. Patients who are currently receiving physical therapy for Achilles tendinopathy, have received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meuhedet. Healthcare Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shmuel Springer, prof

Role: STUDY_DIRECTOR

Ariel University, Physical Therapy Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meuhedet Health Services

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Braunstein M, Baumbach SF, Herterich V, Bocker W, Polzer H. [Acute achilles tendon rupture : State of the art]. Unfallchirurg. 2017 Dec;120(12):1007-1014. doi: 10.1007/s00113-017-0420-4. German.

Reference Type BACKGROUND
PMID: 29038897 (View on PubMed)

Bovend'Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009 Apr;23(4):352-61. doi: 10.1177/0269215508101741. Epub 2009 Feb 23.

Reference Type BACKGROUND
PMID: 19237435 (View on PubMed)

Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

Reference Type BACKGROUND
PMID: 23961782 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MeuhedetHCO1

Identifier Type: -

Identifier Source: org_study_id